Key result
Scoring balloon prep yields ~0.8 mm² larger 6-month minimal lumen area vs. NC balloon before bioresorbable scaffolds.
Why the study?
Lumen reductions over time after bioresorbable scaffold implantation have been reported, prompting investigation into whether scoring balloon lesion preparation minimizes this reduction compared with a standard noncompliant balloon.
Does lesion preparation with a scoring balloon improve minimal lumen area at 6 months compared to a standard noncompliant balloon in patients with stable angina pectoris receiving a Magmaris bioresorbable scaffold?
RCT (n=82)
Single-blind
1:1
No
Does lesion preparation with a scoring balloon improve minimal lumen area at 6 months compared to a standard noncompliant balloon in patients with stable angina pectoris receiving a Magmaris bioresorbable scaffold?
Intense lesion preparation with a scoring balloon improves vessel dynamics and reduces negative remodeling and malapposition 6 months after bioresorbable scaffold implantation.
Supports scoring balloon prep before Magmaris implantation; extends RCT evidence favoring optimized lesion preparation for bioresorbable scaffolds.
BACKGROUND: Bioresorbable scaffolds (BRS) were developed to overcome limitations related to late stent failures of drug-eluting stents, but lumen reductions over time after implantation of BRS have been reported. This study aimed to investigate if lesion preparation with a scoring balloon compared with a standard noncompliant balloon minimizes lumen reduction after implantation of a Magmaris BRS assessed with optical coherence tomography and intravascular ultrasound. METHODS: Eighty-two patients with stable angina were randomized in a ratio of 1:1 to lesion preparation with a scoring balloon versus a standard noncompliant balloon before implantation of a Magmaris BRS. The primary end point was minimal lumen area at 6-month follow-up. RESULTS: Following Magmaris BRS implantation, minimal lumen area (6.4±1.6 versus 6.3±1.5 mm 2 ; P =0.65), mean scaffold area (7.8±1.5 versus 7.5±1.7 mm 2 ; P =0.37), and mean lumen area (8.0±1.6 versus 7.7±2.1 mm 2 ; P =0.41) did not differ significantly in patients with lesions prepared with scoring versus standard noncompliant balloon, respectively. Six-month angiographic follow-up with optical coherence tomography and intravascular ultrasound was available in 74 patients. The primary end point, 6-month minimal lumen area, was significantly larger in lesions prepared with a scoring balloon compared with a standard noncompliant balloon (4.7±1.4 versus 3.9±1.9 mm 2 ; P =0.04), whereas mean lumen area (7.2±1.4 versus 6.8±2.2 mm 2 ; P =0.35) did not differ significantly. Intravascular ultrasound findings showed no difference in mean vessel area at the lesion site from baseline to follow-up in the scoring balloon group (16.8±2.9 versus 17.0±3.6 mm 2 ; P =0.62), whereas mean vessel area (17.1±4.4 versus 15.7±4.9 mm 2 ; P <0.001) was smaller in lesions prepared with a standard noncompliant balloon due to negative remodeling. CONCLUSIONS: Lesion preparation with a scoring balloon before implantation of a Magmaris BRS resulted in a significantly larger minimal lumen area after 6 months due to less negative remodeling compared with lesion preparation with a standard noncompliant balloon. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04666584.
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Hansen et al. (2025) conducted an RCT in Stable angina pectoris (n=82). Lesion preparation with a scoring balloon vs. Lesion preparation with a standard noncompliant balloon was evaluated on Minimal lumen area at 6-month follow-up (p=0.04). Lesion preparation with a scoring balloon before implantation of a Magmaris bioresorbable scaffold resulted in a significantly larger minimal lumen area after 6 months compared with a standard noncompliant balloon (4.7±1.4 vs 3.9±1.9 mm2, P=0.04).
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